This training focuses on understanding design controls for medical devices in accordance with current FDA regulations and learning how an effective Process Validation system is a critical requirement towards a risk-based approach to compliance and product safety.

Topics to be discussed include:

  • 21 CFR Part 820 – QSR scope, definitions and requirements
  • Class I, II, III Medical Device Classification
  • Overview of ISO 14971:2007 and EN ISO 14971:2012 Risk Management standards
  • Discussion of Various Document types – Product Specification, Marketing Specifications, Design Reviews, Design Verification Plan, Design Verification Report, Design Validation Plan, Design Validation Report, Test Method Validation, Design Transfer Plan, Risk Analysis, Design History File
  • Discussions on V&V Strategies, statistical methods, Reliability Assessment, Test Method Validation
  • Risk Evaluation Tools and Methods
  • FTA
  • PHA
  • Process Validation Compliance Requirements
  • Process Validation Elements – Validation Master Plan, Equipment Installation, Operation and Performance Qualifications (IQ, OQ, PQ), Validation Reports
  • Use of Statistical Tools in Validation – Process Capability, T-tests, ANOVA, Data Types

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